Technical Manual
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BRM3 Brain Monitor Technical Manual
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BRM3 Brain Monitor Technical Manual
All product names and brand names in this document are trademarks or registered trademarks of their respective holders. © BrainZ Instruments Ltd, 2003-2007. All rights reserved. No part of this document may be photocopied or reproduced without the prior written consent of BrainZ Instruments Limited. Product specifications may change without prior notice. The BRM3 Brain Monitor is manufactured by: BrainZ Instruments Limited 25 Carbine Road, Mt Wellington, Auckland 1060 PO Box 51078, Pakuranga, Manukau 2140 New Zealand Telephone: Fax: Email: Website:
+64 9 978 8896 +64 9 978 8889 [email protected] www.brainz.com
EU Authorized Representative: BrainZ Instruments UK Limited Fountain Court, 2 Victoria Square, Victoria Street, St Albans Hertfordshire AL1 3TF United Kingdom BRM3 Brain Monitor Technical Manual Part No: Issue No: Issue Date: Iteration:
CZD00071; GE M1119321 1 August 2007 1.6
Table of contents Introduction
1
About this manual ... 1 Conventions used in this document ... 1 Introducing the BRM3 Brain Monitor... 5
Assembling the BRM3 Brain Monitor
6
The packaged BRM3 Brain Monitor... 6 Assembling the Roll Pole... 6 Attaching and connecting the components ... 9
Maintenance
12
Routine maintenance ... 12 Cleaning... 14 Disposal ... 14
Servicing
15
Equipment required for servicing ... 15 Troubleshooting... 15 System Diagnostics screen... 16 Safeguarding data when servicing a BRM3 Brain Monitor... 19 Checking for normal operation... 19 Checking the test plug ... 21 Checking the power supply unit ... 22 Checking the DAU connector ... 23 Electrical safety testing... 24 USB memory sticks ... 24 Upgrading software ... 25 Installing or replacing a battery back-up pack... 25 Replacing the DAU connector... 27 Recalibrating the Touchscreen Monitor using a keyboard... 29 Replacing the Hard Drive... 29
Specifications
32
General specifications ... 32 EEG specifications... 33 DAU specifications... 34 Environmental specifications ... 34 Technical overview... 34 Hardware architecture... 36 Standards compliance information... 37 Declaration of compliance for IEC 60601-1-2 ... 37 Part numbers for BRM3 Brain Monitor components ... 41 Spare parts ... 43 Authorized service centers... 46
Introduction
Introduction About this manual The BRM3 Brain Monitor Technical Manual The BRM3 Brain Monitor Technical Manual contains information required to assemble, maintain and service the BRM3 Brain Monitor, manufactured by BrainZ Instruments Limited, of Auckland, New Zealand. Detailed operating instructions are provided in the BRM Onscreen Help System and the BRM3 Brain Monitor Reference Manual.
Who should read this manual Healthcare institution service personnel should read this document.
Conventions used in this document Warnings, cautions and notes A WARNING identifies actions or situations that could lead to personal injury or death. Take note of all WARNINGS before you operate the BRM3 Brain Monitor. A CAUTION identifies actions or situations that could damage the BRM3 Brain Monitor, or other equipment, or invalidate test results and measurements. Personal injury is unlikely. A NOTE contains advisory information about some aspect of the BRM3 Brain Monitor or its operation, or about a procedure or function.
BRM3 Brain Monitor Technical Manual | 1
Introduction
Terms and abbreviations The following table contains the terms and abbreviations used on the BRM3 Brain Monitor and its packaging, or in this manual and other documentation.
Term or Abbreviation
Meaning
Amplitude-integrated electroencephalogram (aEEG)
A presentation of long EEG recordings collected by a timecompression technique that uses an asymmetrical filter, peak detector, rectifier and semi-logarithmic amplifier.
Amplitude
A measurement of the level of brain activity detected as an electrical signal, measured in microvolts (μV) peak-to-peak.
Artifact
Any electrical signal detected by an EEG machine from an extracerebral source (for example, electrode or cable movement, AC supply noise, ventilator noise).
Assessment
In this document, an 'assessment' refers to an examination of a patient’s EEG activity using the BRM3 Brain Monitor.
Channel
A complete system for the amplification and conditioning of electrical signals from a pair or combination of electrodes.
Data Acquisition Unit (DAU)
The DAU contains the interface between the low-level analog signals detected by the Neonatal Sensor Set or Sensor Adaptor Set and the digital processing software of the BRM3 Brain Monitor. The DAU also contains the medical isolation circuitry used to protect both patient and instrument in the unlikely event of an electrical fault. The DAU is normally positioned close to the patient, often hung at the side of an incubator or cot.
Electrode
Conductor applied over, or inserted into, a region of the scalp to detect electrical activity of the brain.
Electroencephalograph (EEG)
Medical electrical equipment intended for production of graphic recordings and/or a visual display of electrical activity of the brain.
Electromyography (EMG)
Electrical activity associated with muscle movement.
Frequency
The number of complete cycles of repetitive waves in one second, measured in hertz (Hz).
Impedance
The opposition to the flow of an electric current through a conductor giving a measurement of the quality of contact between the electrode and scalp, measured in kOhms.
Intensity
A measurement of the electrical energy present in the frequency band of interest.
Neonatal Sensor Set
A proprietary, non-invasive, self-adhesive sensor array used to collect EEG signals from a neonate's brain.
Reference Electrode
An electrode used as a reference point for the suppression of interfering signals detected by other electrodes or their cables.
Sagital Suture
A serrated line on the top of the skull that marks the junction of the two parietal bones.
Sensor Adaptor Set
A proprietary sensor array for use with sub-dermal needle electrodes, used to collect EEG signals from a neonate's brain.
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Introduction
Spectral Edge Index (SEI)
The SEI is calculated by processing the signals from the patient's brain to obtain the frequency below which 90% of the EEG power spectrum lies, across a signal bandwidth of 2 to 20 Hz. Only EEG data not contaminated by noise, movement or other problems is used in the calculation of SEI. SEI is also known as Spectral Edge Frequency.
Tragus
The prominence in front of the external opening of the ear.
Symbols The following table contains other symbols and icons used on the BRM3 Brain Monitor and its packaging, or in this manual and other documentation.
Symbol or Icon
Meaning Touchscreen Monitor is receiving power when lit. Direct Current. Type BF Equipment. Consult operating instructions. Attention: consult accompanying documents. PS/2 keyboard connector. US only: Caution: US Federal law restricts this device to sale by or on the order of a physician.
Turn anti-clockwise to loosen and unlock the Roll Pole height adjustment.
Turn clockwise to tighten and lock the Roll Pole height adjustment.
EU only: Do not dispose of the BRM3 Brain Monitor as unsorted municipal waste. Equipotential Terminal (connection to hospital grounding/earthing system). USB (connection to DAU, USB memory stick, USB printer).
BRM3 Brain Monitor Technical Manual | 3
Introduction
Order of the screens Procedures may begin "On the Main Menu screen, touch xxx" or "On the Login screen, touch xxx" etc. In each case, it is assumed that the user has already set up the BRM3 Brain Monitor, switched on the equipment and logged in. Instructions for preparing the BRM3 Brain Monitor for use are provided at the beginning of this manual and are not repeated at the beginning of each procedure.
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Introduction
Introducing the BRM3 Brain Monitor The BRM3 Brain Monitor is a three-channel electroencephalograph (EEG) that detects and records small electrical signals from each hemisphere of the patient’s brain.
Figure 1: The BRM3 Brain Monitor System
BRM3 Brain Monitor Technical Manual | 5
Assembling the BRM3 Brain Monitor
Assembling the BRM3 Brain Monitor This section contains information about unpacking the BRM3 Brain Monitor, assembling the Roll Pole supplied with the BRM3 Brain Monitor, attaching the Touchscreen Monitor unit and connecting the components. Read this section as you unpack the BRM3 Brain Monitor from its shipping packaging, and before you begin to assemble the device.
The packaged BRM3 Brain Monitor The BRM3 Brain Monitor is supplied in three cartons containing the: •
Roll Pole components (extendable pole, base with casters, power supply mounting bracket, Accessory Basket assembly and tilt mounting bracket).
•
Touchscreen Monitor, power supply unit, DAU, USB 2.0 cable, USB memory stick and test sensor lead.
•
AC power cable, BRM3 Brain Monitor documentation, the AnalyZe CD, a box of sensors and a sensor application kit.
Note: A packing list, supplied with the BRM3 Brain Monitor, lists the contents of each carton in detail.
Assembling the Roll Pole Stage 1: Unpacking the components 1.
Unpack the components of the Roll Pole onto a large flat work surface. Keep the contents of each carton separate.
2.
Check the cartons carefully for fastenings and accessories (normally packed in small plastic bags).
Stage 2: Attaching the Accessory Basket To ensure stability, the Accessory Basket must be mounted within 32" (80 cm) of the ground. 1.
Clip one of the plastic mounting brackets onto the long side of the Accessory Basket without the extra horizontal reinforcing. See Figure 2.
2.
Slide the mounting bracket up the vertical ribs of the Accessory Basket.
3.
Clip the other mounting bracket directly underneath the first one and slide into position.
4.
Locate the extendable pole.
5.
Slide the Accessory Basket onto the bottom of the extendable pole, positioning it on the lower part of the pole, within 32" (80 cm) of the ground.
6.
Tighten the two Philips screws to fasten the Accessory Basket to the extendable pole.
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Assembling the BRM3 Brain Monitor
Figure 2: Assembling the Accessory Basket
Stage 3: Attaching the base to the extendable pole 1.
Lie the extendable pole on its side on a clear, flat work surface.
2.
Locate the hex nut screw.
3.
Place the base over the stepped end of the extendable pole and insert the hex nut screw through the center hole in the base (a flat washer and spring washer should already be fitted). See Figure 3.
4.
Tighten the hex nut screw with a ½" (13 mm) socket wrench.
5.
Turn the base upright and check that the Roll Pole is steady. If it is unsteady, re-tighten the hex nut screw.
Figure 3: Assembling the base
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Assembling the BRM3 Brain Monitor
Stage 4: Attaching the power supply unit 1.
Locate the AC power cable.
2.
Fasten the AC power cable to the power supply mounting bracket using the Philips screw and washer provided.
3.
Attach the two parts of the power supply mounting bracket to the Roll Pole and tighten the two Philips screws. See Figure 4.
4.
Fasten the power supply unit to the mounting bracket using the two velcro securing straps.
5.
Tidy away the AC power cable by winding it around the cable tidy.
Figure 4: Attaching the power supply unit
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Assembling the BRM3 Brain Monitor
Stage 5: Attaching the tilt mounting bracket Note: If the tilt adjustment lever is not able to move freely, lift it up and out before adjusting it. 1.
Place the tilt mounting bracket on top of the extendable pole and position it on the side opposite the height adjustment knob. Tighten the three Philips screws.
2.
Affix the adhesive plastic screw cover to the top of the tilt mounting bracket.
3.
Tighten the tilt adjustment lever.
4.
Tighten the height adjustment knob.
Tilt adjustment lever
Figure 5: Attaching the tilt mounting bracket
Attaching and connecting the components Stage 1: Attaching the Touchscreen Monitor Before attaching the Touchscreen Monitor, ensure that the height adjustment knob and the tilt adjustment lever are firmly tightened. The Touchscreen Monitor and DAU are packaged in the same carton. 1.
Unpack the Touchscreen Monitor and remove the plastic wrapping. Place the Touchscreen Monitor face down on a clean, smooth work surface.
2.
Locate the four plastic spacers packaged with the tilt mounting bracket. These will sit between the tilt mounting bracket and the Touchscreen Monitor.
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Assembling the BRM3 Brain Monitor
3.
Attach two of the four spacers to the top two holes on the back of the Touchscreen Monitor, turning the screws three complete turns only. The spacers must only be loosely attached at this stage. See Figure 6.
Figure 6: Attaching the top two spacers to the Touchscreen Monitor
4.
Lift the Touchscreen Monitor onto the top two holes of the tilt mounting bracket.
5.
Insert the two spacers over the two bottom holes on the back of the Touchscreen Monitor and tighten the screws fully.
6.
Fully tighten the screws on the upper two spacers.
Figure 7: Attaching the bottom two spacers to the Touchscreen Monitor
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Assembling the BRM3 Brain Monitor
Stage 2: Connecting the components Using the figure below as a guide, connect the: •
DAU to the Touchscreen Monitor using the USB 2.0 cable
•
Power supply cable to the Touchscreen Monitor.
An Equipotential Terminal is provided to optionally connect to a hospital ground/earth system.
Equipotential terminal
Figure 8: Connecting the components
Assembly of the BRM3 Brain Monitor is now complete.
Before first use: •
Select the language to be displayed. When the Login screen first appears, touch the flag corresponding to the language required. For more information see the BRM Onscreen Help System or the BRM3 Brain Monitor Reference Manual.
•
Check the date and time shown on the Main Menu screen and adjust if necessary. For more information see the BRM Onscreen Help System or the BRM3 Brain Monitor Reference Manual.
•
Check for normal operation of the BRM3 Brain Monitor. See Checking for normal operation on page 19.
•
Perform any electrical safety tests required. See Electrical safety testing on page 24.
BRM3 Brain Monitor Technical Manual | 11
Maintenance
Maintenance Routine maintenance Weekly 1.
Archive recently-recorded data files onto the USB memory stick provided with the BRM3 Brain Monitor. See the BRM3 Brain Monitor Reference Manual or the BRM3 Onscreen Help System for more information.
2.
Use a laptop or a desktop PC in conjunction with the USB memory stick, to transfer the archived data files onto other media or a file server for long-term storage.
Quarterly 1.
Use the File Manager to review all data files in the BRM3 Brain Monitor’s internal storage that have been previously archived. See the BRM3 Brain Monitor Reference Manual or the BRM Onscreen Help System for more information. Note that the selected file’s archive status is shown beneath the Internal Storage file list.
2.
Delete those files that have been previously archived and transferred to permanent storage, or are no longer required.
Annually The following checks should be carried out every twelve months, or according to the protocol for checking electrical equipment at your healthcare institution. 1.
Visually check to ensure: -
The AC power cable or attachment plug is not damaged.
-
Connecting cables and connectors are not damaged or worn.
-
Screws used to fasten the Touchscreen Monitor or other accessories to the Roll Pole have not become loose.
-
The hex nut screw and the screws fastening the stabilizing weight underneath the base have not become loose.
-
The equipment has not been dropped, and shows no other obvious signs of damage.
2.
Check for normal operation of the BRM3 Brain Monitor. See Checking for normal operation on page 19.
3.
Check the date and time shown on the Main Menu screen and adjust if necessary.
4.
Perform any electrical safety tests required. See Electrical safety testing on page 24.
If any component of the BRM3 Brain Monitor is missing or damaged, replace the appropriate part and check the BRM3 Brain Monitor for normal operation before using it again. See Checking for normal operation on page 19. Do not use malfunctioning equipment.
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Maintenance
After a change in local time After a change in local time (for example, the start or end of daylight savings time), you should adjust the BRM3 Brain Monitor's system time. See the BRM3 Brain Monitor Reference Manual or the BRM Onscreen Help System for more information.
Calibration DAU Calibration The DAU is factory-calibrated, and does not require periodic re-calibration. Touchscreen Monitor Calibration The Touchscreen Monitor may be recalibrated if it is not responding correctly. This procedure must be performed carefully, for good results. This procedure is only suitable if the Touchscreen Monitor requires fine-tuning. If you cannot perform the following procedure because you cannot touch buttons on the screen accurately, see Recalibrating the Touchscreen Monitor using a keyboard on page 29. To recalibrate the touchscreen from the Login screen: 1.
Touch the BrainZ logo.
2.
Touch Yes to confirm that you want to calibrate the touchscreen. The Touchscreen Calibration screen is displayed.
3.
Using a stylus or pencil, touch the exact center of the four target points carefully, when they appear successively in each corner of the screen.
4.
Touch Press to complete calibration. The touchscreen is automatically recalibrated.
If you miss one of the targets, or “double-tap” the screen, do not touch the Press to complete calibration button. The calibration procedure will restart after 10 seconds. To recalibrate the touchscreen during an assessment or when reviewing an assessment: 1.
Touch Tools to display the Tools menu, then touch Calibrate Touchscreen.
2.
Touch Yes to confirm that you want to calibrate the touchscreen. The Touchscreen Calibration screen is displayed.
3.
Using a stylus or pencil, touch the exact center of the four target points carefully, when they appear successively in each corner of the screen.
4.
Touch Press to complete calibration. The touchscreen is automatically recalibrated.
If you miss one of the targets, or “double-tap” the screen, do not touch the Press to complete calibration button. The calibration procedure will restart after 10 seconds.
BRM3 Brain Monitor Technical Manual | 13
Maintenance
Cleaning The components of the BRM3 Brain Monitor are designed to withstand normal hospital cleaning protocols, however they must not be subjected to any form of sterilization procedure. Note the following cleaning instructions and warnings. BRM3 Brain Monitor (including Touchscreen Monitor), DAU and connecting cables Normal cleaning: Clean by wiping with a soft cloth dampened with detergent and water. After use on an infected baby: Clean by wiping with a soft cloth dampened with 70% v/v isopropyl alcohol (IPA). Allow to dry naturally. Disconnect the BRM3 Brain Monitor and the printer (if fitted) from the AC supply outlet before cleaning. Use only a damp cloth for cleaning. Do not use liquid or spray detergents. Never pour liquid into any opening in any part of the BRM3 Brain Monitor, or submerge any component in liquid. This may cause fire or electrical shock. Do not autoclave any component of the BRM3 Brain Monitor, as serious and irreversible damage may result. Do not clean with concentrated bleach, corrosive chemicals or abrasive cleaning compounds. The Touchscreen Monitor and DAU must not be opened except when being serviced by an Authorized Service Center, or when following written instructions from BrainZ. The surface of the Touchscreen Monitor is resistant to the following substances (at room temperature): •
Acetone
•
Methylene chloride
•
Isopropyl alcohol
•
Hexane
•
Ammonia-based glass cleaners
•
Turpentine
•
Mineral spirits
•
Methyl ethyl keytone.
Disposal EU only: Do not dispose of the BRM3 Brain Monitor as unsorted municipal waste at the end of the product's lifetime. Recycle this product in accordance with the regulations for your country. The BRM3 Brain Monitor is categorized as Electrical and Electronic Equipment under the WEEE Directive 2002/96/EC. To arrange for the return or collection of the BRM3 Brain Monitor, contact an Authorized Service Center. See Authorized service centers on page 46.
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Servicing
Servicing Equipment required for servicing In order to perform the servicing procedures described in this section, you will need these items of equipment: •
Multimeter
•
A selection of screwdrivers
•
Test plug (supplied with the BRM3 Brain Monitor, attached to the DAU strap)
•
Test sensor lead (supplied with the BRM3 Brain Monitor)
•
A selection of Allen wrenches
•
A PS/2 (non-USB) computer keyboard.
Troubleshooting Message codes If the BRM3 Brain Monitor fails to perform as described in this Technical Manual or according to the BRM Onscreen Help System, or when a warning message is displayed in the Signal Status screen, refer to the following table: Problem or warning message
Explanation
Message 31: Check sensor electrode leads and connections, secure or reapply if necessary.
One or more sensors are not making contact. Sensor contact impedance is high.
Message 32: Ensure there is no contact between adjacent sensors.
Sensor contact impedance is low. Check for touching electrodes, or conductive material between the electrodes. Reapply sensors if necessary.
Message 33: Apply warmth and gentle pressure to sensors and monitor impedance. Re-hydrate sparingly only if necessary.
Sensor contact impedance is marginally high. An electrode is drying out or lifting. Rehydrate the sensors with sterile water. Apply gentle pressure and monitor impedance. If the impedance stays below 10 kOhms a satisfactory assessment can be made. If necessary, reapply sensors.
Message 35: Impedance is changing, check for patient movement.
Sensor contact impedance has changed more than 20% in the past four seconds. Impedance is changing, signal may be contaminated by movement. Check for patient movement, and that the sensors are securely attached.
Message 36: Connect Data Acquisition Unit, check UTP or USB DAU cables. If fitted, check isolation unit serial cable and DC power cable.
DAU (Data Acquisition Unit) cannot be detected. Check cable connections between Touchscreen Monitor and DAU.
BRM3 Brain Monitor Technical Manual | 15
Servicing
Message 38: Check Reference electrode, use only BrainZ Sensor Set or Sensor Adaptor Set.
DAU input is saturated.
Message 39: Check Reference electrode, use only BrainZ Sensor Set or Sensor Adaptor Set.
DAU output is clipping.
Message 41: Check Reference electrode, move BRM3 Brain Monitor away from other equipment.
50 or 60 Hz AC Supply Noise is too high. This error probably means that the Reference electrode is improperly applied. Check Reference electrode, reapply if necessary, then move BRM3 Brain Monitor away from other equipment. If problem persists, call Technician.
Driven reference has been disabled for Left channel. Message 46: Left sensor contact impedance is very high or left sensor is not connected. Check Left sensors, secure if necessary, or continue to record on one channel only. Driven reference has been disabled for Right channel. Message 47: Right sensor contact impedance is very high or right sensor is not connected. Check Right sensors, secure if necessary, or continue to record on one channel only. Message 48: Waiting to start recording: Apply BrainZ Sensor Set or Sensor Adaptor Set to patient, then touch the start button.
Sensors have not been applied to patient.
If none of these conditions apply, or if the suggested remedy is ineffective: •
Check for correct operation of the BRM3 Brain Monitor, by using the test plug. See Checking for normal operation on page 19.
•
Check BrainZ Instruments Limited's web site, www.brainz.com (http://www.brainz.com) for additional support information.
•
Proceed with the troubleshooting flowchart overleaf.
System Diagnostics screen A System Diagnostics screen is provided for use when troubleshooting problems with the BRM3 Brain Monitor. The screen is divided into modules relating to the operating and performance characteristics of the BRM3 Brain Monitor system. Only perform a system diagnostic analysis if you are advised to do so by an Authorized Service Center. To access the System Diagnostics screen: 1.
On the Main Menu screen, touch System Setup to display the System Setup screen.
2.
Touch System Diagnostics to display the System Diagnostics screen.
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